EU → US Device Access

Calzificio Pinelli Srl

IT-MF-000005917 · Italy · Castel Goffredo (Mn)

Calzificio Pinelli Srl is registered in the European database on medical devices as a manufacturer, with 3 716 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa3 716

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCALZIFICIO PINELLI SRL (IT) · FDA 3007084481
Devices in EUDAMED3 716
Country of registrationItaly

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